The Application of Target Controlled Infusion of Etomidate Combined With Propofol in the Maintenance of Anesthesia During Brain Surgeries

NCT ID: NCT02174120

Last Updated: 2014-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-09-30

Brief Summary

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To explore the application of target controlled infusion of etomidate combined with propofol in the maintenance of anesthesia during brain surgeries.

Detailed Description

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Conditions

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Target Controlled Infusion General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A

During maintenance of anesthesia, etomidate was give by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml to keep bispectral index between 40 to 60.

Group Type EXPERIMENTAL

etomidate

Intervention Type DRUG

Group B

During maintenance of anesthesia, Propofol was give by target controlled infusion, the effect-site concentration is 2 to 4 micrograms/ml to keep bispectral index between 40 to 60.

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

Group C

During maintenance of anesthesia, etomidate will be given by target controlled infusion for 2 h first, and then propofol will be given by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml and 2 to 4 micrograms/ml, respectively. Bispectral index should be kept between 40 to 60.

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

etomidate

Intervention Type DRUG

Interventions

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propofol

Intervention Type DRUG

etomidate

Intervention Type DRUG

Other Intervention Names

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Fu Er Li

Eligibility Criteria

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Inclusion Criteria

* Aged between 60 and 80 years Brain surgeries Body weight is between 45 to 75 kg and body mass index is no more than 30 kg/m2 American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ Expected operation duration is between 3 and 5 h Signed informed consent form

Exclusion Criteria

* Serious cardiac, cerebral(acute stroke, uncontrolled seizure, sever dementia), liver, kidney, lung, endocrine disease or sepsis History of general anesthesia within 24 h before the operation Long use of hormone or history of adrenal suppression Hyperlipidaemia Long use of psychotropic substances Systolic pressure is still under 90 mm Hg after twice given of vasopressor agent Suspected abuse of narcotic analgesia Patients need to use neuromuscular blocking drugs (except intubation) Allergy to trial drug or other contraindication Pregnant or breast-feeding women Attendance of other trial past 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liu He

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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20140623

Identifier Type: -

Identifier Source: org_study_id

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